Apparatus and methods for sealing a vascular puncture

ABSTRACT

An apparatus for sealing a puncture through tissue to a vessel includes an elongate occlusion member including an expandable member, a cartridge carried on the occlusion member, and a sealant carried within the cartridge. The cartridge includes an outer member and a pusher member within the outer member. The sealant is disposed within the outer member adjacent the expandable member distal to the pusher member. During use, the occlusion member is introduced into a puncture until the expandable member and the sealant extend from the puncture into the vessel. The expandable member is expanded, and withdrawn until the expanded expandable member contacts the vessel wall, thereby withdrawing the sealant back into the puncture. The outer member is withdrawn to expose the sealant within the puncture, while the pusher member prevents removal of the sealant, and then the cartridge, occlusion member, and pusher member are successively removed.

This application claims benefit of co-pending provisional applicationSer. No. 60/825,410, filed Sep. 13, 2006, the entire disclosure of whichis expressly incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods forsealing punctures in a body, and more particularly, to apparatus andmethods for sealing a vascular puncture extending through tissue, and/orto apparatus and methods for delivering a sealant into a percutaneouspuncture extending from a patient's skin to a blood vessel or other bodylumen to seal the puncture.

BACKGROUND

Apparatus and methods are known for accessing a patient's vasculaturepercutaneously, e.g., to perform a procedure within the vasculature, andfor sealing the puncture that results after completing the procedure.For example, a hollow needle may be inserted through a patient's skinand overlying tissue into a blood vessel. A guide wire may be passedthrough the needle lumen into the blood vessel, whereupon the needle maybe removed. An introducer sheath may then be advanced over the guidewire into the vessel, e.g., in conjunction with or subsequent to one ormore dilators.

A catheter or other device may be advanced through the introducer sheathand over the guide wire into a position for performing a medicalprocedure. Thus, the introducer sheath may facilitate accessing and/orintroducing various devices into the vessel, while minimizing trauma tothe vessel wall and/or minimizing blood loss. Upon completing theprocedure, the device(s) and introducer sheath may be removed, leaving apuncture extending between the skin and the vessel wall.

To seal the puncture, external pressure may be applied to the overlyingtissue, e.g., manually and/or using sandbags, until hemostasis occurs.This procedure, however, may be time consuming and expensive, requiringas much as an hour of a medical professional's time. It is alsouncomfortable for the patient, and may require the patient to remainimmobilized in the operating room, catheter lab, or holding area. Inaddition, a risk of hematoma exists from bleeding before hemostasisoccurs.

Accordingly, apparatus and methods for sealing a puncture through tissuewould be useful.

SUMMARY OF THE INVENTION

The present invention is directed to apparatus and methods for sealing apuncture through tissue, for example, for delivering a sealant into apercutaneous puncture extending from a patient's skin to a blood vesselor other body lumen.

In accordance with one embodiment, an apparatus is provided for sealinga puncture extending through tissue. Generally, the apparatus includesan elongate occlusion member, a cartridge carried on the occlusionmember, and a sealant carried within the cartridge. The occlusion membermay include a proximal end, a distal end sized for insertion into apuncture through tissue, and an expandable member on the distal end.

The cartridge may include an outer member including a proximal end, adistal end sized for insertion into a puncture through tissue, and thesealant may be disposed within the outer member adjacent the expandablemember. In addition, the cartridge may include an inner pusher memberdisposed within the outer member adjacent to the sealant for preventingsubstantial proximal movement of the sealant. The outer member may bemovable proximally from a first position where the outer member distalend covers the sealant and is disposed adjacent the expandable member,to a second position for exposing the sealant.

Optionally, in the first position, the outer member distal end may alsoat least partially cover the expandable member. In this option, atransition cuff may be provided on the occlusion member distal to theexpandable member, the cuff extending over the outer member distal endin the first position and extending at least partially over theexpandable member when the outer member is directed to the secondposition. The transition cuff may be sufficiently flexible toaccommodate expansion of the expandable member. For example, the cuffmay be sufficiently expandable such that the cuff expands when theexpandable member is expanded. In addition or alternatively, the cuffmay extend only partially over the expandable member such that the cuffis directed distally when the expandable member is expanded.

In an exemplary embodiment, the sealant may be a freeze-dried orlyophilized hydrogel, e.g., including hydrolytically degradable bondsand/or being expandable when exposed to an aqueous physiologicalenvironment. In addition or alternatively, the sealant may include alumen extending between proximal and distal ends thereof, e.g., forreceiving the occlusion member therethrough.

Optionally, a removable stop may be provided that extends between theproximal end of the outer member and the proximal end of the occlusionmember for preventing proximal movement of the outer member relative tothe occlusion member until the stop is removed.

In accordance with another embodiment, an apparatus is provided forsealing a puncture extending through tissue that includes an elongateocclusion member and a cartridge. The occlusion member may include aproximal end, a distal end sized for insertion into a puncture throughtissue, and an expandable member on the distal end. The cartridge may becarried on the occlusion member, and may include an outer tubular memberincluding a proximal end, a distal end sized for insertion into apuncture through tissue, and a lumen extending between the proximal anddistal ends.

A sealant may be disposed within the outer tubular member adjacent theexpandable member in a first position, the outer member movableproximally from the first position to a second position to expose thesealant. A transition cuff may be provided on the occlusion memberdistal to the expandable member, the cuff extending over the outermember distal end in the first position and extending at least partiallyover the expandable member when the outer member is moved from the firstposition to the second position.

In accordance with still another embodiment, an apparatus is providedfor sealing a puncture extending through tissue that includes anelongate occlusion member including a proximal end, a distal end sizedfor insertion into a puncture through tissue, and an expandable memberon the distal end. A cartridge may be carried on the occlusion memberthat includes an outer tubular member including an outer member proximalend, an outer member distal end sized for insertion into a puncturethrough tissue, and a lumen extending between the outer member proximaland distal ends. The outer member may be movable from a first positionwherein the outer member distal end at least partially covers theexpandable member and a second position wherein the expandable member isexposed.

The cartridge may also include an inner tubular member slidably disposedwithin the outer tubular member, the inner tubular member includinginner member proximal and distal ends, the inner member distal enddisposed adjacent the outer member distal end when the outer tubularmember is in the second position. A sealant may be disposed within theinner tubular member adjacent the inner member distal end.

In addition, the cartridge may include a housing attached to the innermember proximal end, the outer tubular member being slidable axiallyrelative to the housing, the housing limiting axial movement of theouter tubular member between the first and second positions.

A pusher member may also be disposed within the inner tubular member,e.g., adjacent the sealant, for preventing substantial proximal movementof the sealant when the inner tubular member is moved proximallyrelative to the sealant.

In accordance with yet another embodiment, a method is provided forsealing a puncture extending through tissue to a body lumen, e.g., usingan apparatus that includes an elongate occlusion member including anexpandable member on a distal end thereof, a tubular member slidablydisposed around the occlusion member, and a sealant disposed within thetubular member adjacent the expandable member. The occlusion memberdistal end may be introduced into the puncture with the expandablemember in a contracted condition until the expandable member and thesealant extend from the puncture into the body lumen. The expandablemember may be expanded, and then at least partially withdrawn until theexpanded expandable member contacts a wall of the body lumen adjacentthe puncture, thereby withdrawing the sealant back into the puncture.The tubular member may be withdrawn to expose the sealant within thepuncture.

In accordance with still another embodiment, a method is provided forsealing a puncture extending through tissue to a body lumen using anapparatus including an occlusion member including an expandable memberon a distal end thereof, and a cartridge including an outer member and asealant within the outer member adjacent the expandable member, and atransition cuff on the occlusion member distal to the expandable member,the cuff extending over a distal end of the outer member. The occlusionmember distal end may be introduced through the puncture into the bodylumen with the cuff extending over the distal end of the outer member.

The outer member may be retracted to expose the expandable member withinthe body lumen, the cuff extending at least partially over theexpandable member, and the expandable member may be expanded within thebody lumen. The occlusion member may be at least partially withdrawnfrom the puncture until the expanded expandable member substantiallyseals the body lumen from the puncture and/or otherwise contacts a wallof the body lumen adjacent the puncture.

The outer member may be withdrawn to expose the sealant within thepuncture. Optionally, the cartridge may include a pusher member withinthe outer member adjacent the sealant, the pusher member preventingsubstantial proximal movement of the sealant when the outer member iswithdrawn to expose the sealant.

Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first exemplary embodiment of anapparatus for delivering sealant into a puncture through tissue,including an occlusion member and a cartridge carrying the sealant.

FIGS. 2A and 2B are cross-sectional views of the apparatus of FIG. 1,showing an outer member of the cartridge covering the sealant andretracted to expose the sealant, respectively.

FIGS. 3A-3D are cross-sectional views of a patient's body, showing amethod for sealing a puncture extending through tissue to a body lumenusing the apparatus of FIG. 1.

FIGS. 4A-4C are cross-sectional views of a second embodiment of anapparatus for delivering a sealant into a puncture through tissue,showing the apparatus manipulated between first, second, and thirdpositions, respectively.

FIG. 5A is a side view showing a stop disposed between the cartridge andocclusion member of the embodiment of FIG. 1.

FIG. 5B is a cross-sectional view of the stop of FIG. 5A, taken alongline 5B-5B.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Turning to the drawings, FIGS. 1-2B shows a first exemplary embodimentof an apparatus 10 that generally includes an elongate occlusion member40, a cartridge 18 carried by the occlusion member 40, and a sealantcarried by the cartridge 18. Generally, the cartridge 18 may include anouter tubular member 20, and an inner pusher member 30 (see FIGS.2A-2B). Optionally, as described further elsewhere herein, the cartridge18 may include a housing or handle 80, an inner tubular member (notshown), e.g., disposed between the outer tubular member 20 and thepusher member 32, and/or a transition cuff (also not shown) between theocclusion member 40 and the cartridge 18, as described in the variousembodiments herein.

The outer tubular member 20 may be a substantially rigid, semi-rigid,and/or flexible tubular body, including a proximal end 22, a distal end24 sized and/or shaped for insertion into a puncture, and a lumen 26,e.g., extending between the proximal and distal ends 22, 24. The lumen26 may be sized for receiving the sealant 2 and/or the pusher member 30therein, e.g., such that the outer tubular member 18 is slidablerelative to the sealant 2 and/or pusher member 30 during use, asdescribed elsewhere herein. The distal end 24 may be tapered and/or mayinclude a substantially atraumatic tip to facilitate advancement througha puncture.

The pusher member 30 may be an elongate tubular member, e.g., a plunger,catheter, tamping tube, and the like, including a proximal end 32, and adistal end 34 having a size for slidable insertion into the lumen 26 ofthe outer tubular member 20. The distal end 34 of the pusher member 30may be substantially blunt, e.g., to facilitate contacting, pushing,compressing, and/or otherwise tamping the sealant 2, e.g., upon exposureand/or delivery into a puncture, as described elsewhere herein. Thepusher member 30 may be substantially rigid, semi-rigid, and/orsubstantially flexible, having sufficient column strength to allowmovement of the outer member 20 relative to the pusher member 30 andsealant 2 without buckling the pusher member 30. The pusher member 30may also include a lumen 36 extending between the proximal end 32 andthe distal end 34, e.g., to accommodate the elongate occlusion member 40and/or a guidewire (not shown).

The sealant 2 may be carried by the cartridge 18, e.g., within the lumen26 of the outer tubular member 20 adjacent to the distal end 24.Generally, the sealant 2 may have a cylindrical shape, e.g., including alumen 4 extending between ends of the sealant, as shown. Alternatively,the sealant 2 may have other cross-sections or shapes, such aselliptical, triangular, square, conical, disk, polygonic shapes, and thelike.

The sealant 2 may be formed from a biocompatible and/or bioabsorbablematerial, for example, a porous, bioabsorbable foam or other solidmaterial. In one embodiment, the sealant 2 may be formed from abiocompatible and/or bioabsorbable hydrogel, e.g., polyethylene glycol(“PEG”), or other synthetic material. Exemplary hydrogel materials andmethods for making them are disclosed in co-pending application Ser. No.11/465,791, filed Aug. 18, 2006, the entire disclosure of which isexpressly incorporated by reference herein.

In addition or alternatively, the sealant 2 may include pro-thromboticmaterial, e.g., including one or more biological pro-thrombotics, suchas collagen, fibrin, carboxymethylcellulose, oxidized cellulose,alginates, gelatin, or other protein-based material, and/or syntheticmaterials, such as polyglycolic acids (PGA's), polyactides (PLA's),polyvinyl alcohol, and the like. The material of the sealant 2 may be atleast partially absorbed by the body over time, e.g., over a period ofdays, weeks, or months. Optionally, the sealant 2 may includetherapeutic and/or pharmaceutical agents, e.g., to promote healing,prevent infection and/or other adverse medical events, and the like.Such agents may be embedded in the sealant material and/or applied asone or more coatings or layers. In addition, the material of the sealant2 may have a substantially uniform composition or the composition may bevaried, e.g., along its length and/or within underlying layers withinthe sealant 2.

Optionally, the sealant 2 may include first and/or second hydrogelprecursors (not shown), which may remain in an unreactive state, e.g.,before or until exposure to an aqueous physiological environment. Anaqueous physiological environment may exist, for example, inside apuncture track extending through tissue. For example, blood or otherbodily fluids that contact the precursor-laden sealant 2 may initiate ahydrogel forming reaction between the two precursors. The reaction ofthe hydrogel precursors may form a cross-linked adhesive or tackycoating that may aid in retaining the sealant 2 within a puncture afterdeployment and/or in facilitating hemostasis within the puncture.

Optionally, an activating agent, e.g., a pH adjusting material (notshown), may also be disposed on the sealant 2 to initiate, accelerate,or otherwise enhance the reaction of the precursors. For example, the pHactivating agent may create a localized change in pH after exposure to ahydrous or aqueous environment, e.g., to initiate or accelerate thehydrogel-forming reaction.

The hydrogel precursor(s) may include any number of hydrogel precursormaterials, such as those disclosed in U.S. Pat. Nos. 6,152,943,6,165,201, 6,179,862, 6,514,534, 6,379,373, 6,703,047, and in co-pendingapplication Ser. Nos. 10/010,715 filed Nov. 9, 2001, Ser. No. 10/068,807filed Feb. 5, 2002, and Ser. No. 10/454,362, filed Jun. 4, 2003. Thedisclosures of these references and any others cited therein areexpressly incorporated by reference herein. Additional informationregarding providing a sealant, e.g., including a core member and/orhydrogel precursors, may be found in co-pending application Ser. Nos.10/982,387 and 10/982,384, both filed Nov. 5, 2004, the entiredisclosures of which are expressly incorporated by reference herein.

With continued reference to FIG. 1, the occlusion member 40 may includea solid or hollow elongate body, including a proximal end 42, a distalend 44, and an expandable member 46 on the distal end 44. The expandablemember 46 may be an inflatable and/or mechanically expandable element,such as a balloon, as shown, a wire mesh structure (not shown), anexpandable frame (also not shown), and the like, as described in theapplications incorporated by reference elsewhere herein. Optionally, theexpandable member 46 may include a skin or other covering (not shown) onat least a proximal portion thereof, thereby making the expandablemember 46 substantially nonporous. In addition or alternatively, atleast a portion of the expandable member 46, may include a lubriciouscoating, e.g., a proximal portion and/or a covering extending at leastpartially over the expandable member 46.

The expandable member 46 may be selectively expandable, e.g., using oneor more of a source of inflation media, e.g., a syringe 50 coupled to alumen (not shown) extending through the elongate occlusion member 40 toan interior of the expandable member 46, a pull wire (not shown), orother actuator (also not shown) operable from the proximal end 42 of theelongate occlusion member 40. For example, as shown in FIG. 1, theocclusion member 40 may include a housing 48 on the proximal end 42including a port 49 communicating with the syringe 50. The housing 48may communicate with an interior of the expandable member 46 via aninflation lumen (not shown) extending between the proximal and distalends 42, 44.

Alternatively, the expandable member 46 may be biased to the enlargedcondition, but may be compressed to the contracted condition, e.g., byan overlying sleeve or other constraint (not shown). The constraint maybe removed to expose the expandable member 46, allowing the expandablemember 46 to automatically expand to the enlarged condition. Additionalinformation on expandable structures that may be incorporated intoelongate occlusion member 40 may be found in U.S. Pat. Nos. 6,238,412and 6,635,068, in co-pending application Ser. Nos. 10/454,362, filedJun. 4, 2003, 10/806,952, filed Mar. 22, 2004, 10/143,514, published asPublication No. US 2003/0078616 A1, and 11/112,877, filed Apr. 22, 2005,and 11/112,971, filed Apr. 22, 2005. The entire disclosures of thesereferences are expressly incorporated herein by reference.

The outer tubular member 20 may be movable relative to the occlusionmember 40, e.g., from a distal or first position where the distal end 24of the outer tubular member 20 is disposed adjacent the expandablemember 46 and covers the sealant 2 (FIG. 2) to a proximal or secondposition where the distal end 24 is retracted sufficiently to expose thesealant 2.

Optionally, as shown in FIGS. 5A and 5B, a removable spacer or otherstop 70 may be provided that may extend along the occlusion member 40,e.g., between the housing 80 on the cartridge 18 and the housing 48 onthe occlusion member 40. For example, the stop 70 may be an elongatemember 72 having a “C” shaped cross-section, allowing the stop 70 to besnapped or otherwise received around the occlusion member 40. The stop70 may have sufficient length such that a first end 76 thereof abuts theproximal end 22 of the outer tubular member 20 and/or the housing 80 inthe first position and a second end 74 thereof abuts the housing 48 onthe proximal end 42 of the occlusion member 40. Thus, with the stop 70received around the occlusion member 40, proximal movement of the outertubular member 40 from the first position shown in FIG. 2A is prevented.The stop 70 may be peeled or otherwise separated from around theocclusion member 40, e.g., by pulling tab 78 or other handle (notshown), thereby allowing the outer tubular member 20 to be subsequentlydirected proximally.

Returning to FIG. 2B, with the stop removed, the outer tubular member 20may be directed proximally to the second position to expose the sealant2. To facilitate retraction of the outer tubular member 20, a raisedslider ring, handle, or other radial element 28 may be provided on theouter tubular member 20 between the proximal and distal ends 22, 24. Theslider ring 28 may be attached to an outer surface of the outer tubularmember 20. Alternatively, the slider ring 28 may be integrally formedwith the outer tubular member 20 or may be a separate proximal extensionattached to the outer tubular member 20, e.g., at least partiallydefining the proximal end 22 of the outer tubular member 20.

Turning to FIGS. 3A-3D, an exemplary method is shown for sealing apuncture 90 using the apparatus 10. Generally, the puncture 90 mayextend from a patient's skin 92 through intervening tissue 96, e.g., toa body lumen 94. In an exemplary embodiment, the puncture 90 may be apercutaneous puncture communicating with a blood vessel 94, such as afemoral artery, carotid artery, and the like.

In an exemplary method, the puncture 90 may be created using knownprocedures, e.g., using a needle, guidewire, one or more dilators, andthe like (not shown). An introducer sheath 98 may be advanced throughthe puncture 90 into the vessel 94, e.g., to provide access into thevessel 90 for one or more instruments, and/or allow one or morediagnostic and/or interventional procedures to be performed via thevessel 90. Upon completing the procedure(s) via the vessel 94, anyinstruments and/or the introducer sheath 98 may be removed from thepuncture 90.

Turning to FIG. 3A, with the expandable member 46 collapsed, theapparatus 10 may be introduced into the puncture 90, e.g., by insertingthe distal end 44 of the occlusion member 40 into the introducer sheath98 (if the introducer sheath has not already been removed from thepuncture 90 after using the introducer sheath 98 to access the vessel94). As the distal end 44 of the occlusion member 40 is advanced throughthe introducer sheath 98 and puncture 90, the cartridge 18, e.g., thedistal end 24 of the outer tubular member 20, follows the expandablemember 46 through the puncture 90 and into the vessel 94. Thus, thesealant 2 within the cartridge 18 may be advanced through the puncture90 and into the vessel 94, while remaining within the outer tubularmember 20.

The occlusion member 40 and cartridge 20 may be sufficiently long suchthat, when the slider ring 28 (not shown in FIG. 3A) contacts a proximalend 98 a of the introducer sheath 98, the occlusion member 40 extendsdistally beyond a distal end 98 b of the introducer sheath 98. Inaddition or alternatively, the occlusion member 40 may include distancemarkers, bands, numbers, and the like (not shown), to indicate to theuser the depth to which the occlusion member 40 has been inserted, whichmay facilitate confirming that the apparatus 10 has been advancedsufficiently to dispose the expandable member 46 within the vessel 94beyond the distal end 98 b of the introducer sheath 98.

Turning to FIG. 3B, once the expandable member 46 is disposed within thevessel 94 beyond the introducer sheath 98, the expandable member 46 maybe expanded, e.g., by delivering inflation media into the expandablemember 46. With the expandable member 46 expanded, the apparatus 10 maybe withdrawn until the expanded expandable member 46 contacts a wall ofthe vessel 94 immediately adjacent the puncture 90.

For example, the apparatus 10 may be retracted until the expandablemember 46 contacts the distal end 98 b of the introducer sheath 98.Further withdrawal of the apparatus 10 may cause the expandable member46 to push the introducer sheath 98 at least partially out of thepuncture 90 until the expandable member contacts the wall of vessel 94immediately adjacent the puncture 90, similar to methods described inapplication Ser. No. 10/982,384, incorporated by reference elsewhereherein. Proximal tension may be maintained on the occlusion member 40 tosubstantially seal the puncture 90 from the vessel 94 using theexpandable member 46 or simply to maintain the expandable member 46 incontact with the wall of the vessel 90 and/or to maintain the occlusionmember 40 under tension.

Turning to FIG. 3C, the outer tubular member 20 may then be retracted toexpose the sealant 2 within the puncture 90. For example, the introducersheath 98 may be withdrawn from the puncture 90, thereby causing theintroducer sheath 98 to contact the slider ring 28 and pull the outertubular member 20 proximally out of the puncture 90. Alternatively, theouter tubular member 20 may be withdrawn before withdrawing theintroducer sheath 98 or the introducer sheath 98 may have been withdrawnbefore introducing the apparatus 10. As shown, the inner pusher membermay be at least partially exposed as the outer tubular member 20 (andintroducer sheath 98) are withdrawn from the puncture 90.

With additional reference to FIGS. 2A and 2B, the occlusion member 40may include a stop 43 that prevents proximal movement of the pushermember 30 while the outer tubular member 20 is retracted. Otherwise, thepusher member 30 may be free to slide distally relative to the occlusionmember 40 (but for the sealant 2). Thus, the pusher member 30 may remainsubstantially stationary while the outer tubular member 20 is retracted.Consequently, the sealant 2 may abut the distal end 34 of the pushermember 30 to prevent the sealant 2 from also moving proximally while theouter tubular member 20 is retracted.

If desired, the pusher member 30 may be used to compress, pack, orotherwise tamp the sealant 2 within the puncture 90. For example, afterthe sealant 2 is exposed within the puncture 90, the pusher member 30may be advanced manually to tamp the sealant 2 distally against theexpandable member 46. This may place the distal end 16 of the sealant 2adjacent to or against the wall of the vessel 94 and/or deform thesealant 2, which may enhance hemostasis in the arteriotomy between thevessel 94 and the puncture 90.

Optionally, after the sealant 2 is deployed within the puncture 90,additional sealing compound may be delivered into the puncture 90, e.g.,to fill all or a portion of the puncture 90 above and/or around thesealant 2. For example, the lumen 36 of the inner pusher member 30 maybe used to deliver liquid sealing compound, e.g., hydrogel precursors(not shown), into the puncture 90. Exemplary apparatus and methods fordelivering such sealing compounds into the puncture 90 are disclosed inco-pending application Ser. Nos. 10/454,362 and 10/806,952, filed Mar.22, 2004, the entire disclosures of which are expressly incorporated byreference herein.

Turning to FIG. 3D, the occlusion member 40 may be withdrawn through thesealant 2 and the lumen 36 of the inner pusher member 30. The innerpusher member 30 may restrain the sealant 2 from moving proximally asthe elongate occlusion member 40 is removed. Thus, the occlusion member40, which may still carry the outer tubular member 20 and/or introducersheath 98, may be completely removed, leaving the pusher member 30 andsealant 2 within the puncture. Once the elongate occlusion member 40 isremoved, the pusher member 30 may be removed, leaving the sealant 2 toseal the puncture 90.

When the expandable member 46 is collapsed, blood and/or other fluidwithin the vessel 94 may enter the puncture 90, thereby exposing thesealant 2 to an aqueous physiological environment. The aqueousphysiological environment, which may include blood or other bodilyfluids from the vessel 94 (or other body lumen) may wet the sealant 2,thereby hydrating the sealant material and/or initiating a reactionbetween precursor components carried by the sealant 2, as described inthe applications incorporated by reference above.

Turning now to FIGS. 4A-4C, another exemplary embodiment of an apparatus110 is shown that generally includes an occlusion member 140, acartridge 118, and a sealant 102, similar to the previous embodiments.The occlusion member 140 includes an elongate member having a proximalend 142, a distal end 144, and an expandable member 146 on the distalend 144, also similar to previous embodiments.

The cartridge 118 generally includes an outer tubular member 120, and aninner pusher member 130, also similar to the previous embodiments. Theouter tubular member 120 may be a tubular member including a proximalend 122, a distal end 124 sized and/or shaped for introduction into apuncture (not shown), and a lumen 126 extending therebetween.

Unlike the previous embodiments, the cartridge 118 also includes aninner tubular member 170 disposed between the outer tubular member 120and the pusher member 130, and a housing 180 on the proximal end 122 ofthe outer tubular member 120, e.g., coupled to at least one of the outertubular member 120 and the inner tubular member 170. As shown, the innertubular member 170 includes a proximal end 172 coupled to an inner hub182 within the housing 180, a distal end 174 disposed over the sealant102, and a lumen 176 extending between the proximal and distal ends 172,174, e.g., for slidably receiving the sealant 102 and pusher member 130.Initially, the distal end 174 of the inner tubular member 170 may bedisposed proximal to the distal end 124 of the outer tubular member 120,as described further below.

The inner tubular member 170 may be substantially stationary relative tothe housing 180, e.g., by fixing the inner hub 182 within or otherwiserelative to the housing 180. For example, the inner hub 182 may beshaped to sit within a correspondingly shaped cavity within the housing180. In addition or alternatively, the inner hub 182 may be secured tothe housing 180, e.g., using adhesives, connectors, sonic welding,fusing, and the like.

The outer tubular member 120 may be slidable axially relative to thehousing 180, inner tubular member 170, and/or the occlusion member 140.For example, the outer tubular member 120 may be slidable proximallyrelative to the housing 180 (and inner tubular member 170 if fixedrelative to the housing 180) between a distal or first position, shownin FIG. 4A, and a proximal or second position, shown in FIG. 4B. Asshown in FIG. 4A, the outer tubular member 120 is shown in the firstposition, e.g., in which the apparatus 110 may be initially provided toa user. In the first position, the distal end 124 of the outer tubularmember 120 may overly the expandable member 46, i.e., distally beyondthe distal end 174 of the inner tubular member 170 and the sealant 2disposed within the inner tubular member 170. Thus, the distal end 124of the outer tubular member 120 may cover all of the other components ofthe apparatus 110 to facilitate introduction into a puncture.

Optionally, as shown in FIGS. 4A and 4B, a transition cuff or sleeve 150may be provided on the distal end 144 of the occlusion member 140distally beyond the expandable member 146. The transition cuff 150 maybe formed from a substantially thin-walled and/or flexible material,e.g., similar to the expandable element 146. The transition cuff 150 mayprovide a substantially atraumatic tip for the apparatus 110. As shownin FIG. 4A, initially, the distal end 144 of the occlusion member 140may extend distally beyond the distal end 124 of the outer tubularmember 120, and the transition cuff 150 may extend from the distal end144 of the occlusion member 140 over the distal end 124 of the outertubular member 120.

As shown in FIG. 4B, when the outer tubular member 120 is retracted tothe second position, the transition cuff 150 may be separated from thedistal end 124 of the outer tubular member 120. The transition cuff 150may extend loosely over the expandable member 146 or may resilientlyretract to expose the expandable member 146. When the expandable element146 is subsequently expanded, the transition cuff 150 may slide off thedistal end of the expandable element 146 and/or otherwise fold orcollapse adjacent to the expandable element 146.

If desired, a lubricious coating may be applied to the transition cuff150 and/or the expandable member 146, e.g., to ease the transition cuff150 sliding or otherwise retracting from over the expandable memberduring the expansion of the expandable element 146. Alternatively, thematerial of the transition cuff 150 may be sufficiently resilient toexpand when the expandable member 146 is expanded, instead of slidingoff the expandable member 146.

With additional reference to FIGS. 4B and 4C, the housing 180, includingthe inner and outer tubular members 170, 120 may be movable togetherfrom the second position, shown in FIG. 4B, to a third position, shownin FIG. 4C, wherein the distal ends 174, 124 of the inner and outertubular members 170, 120 are retracted sufficiently to expose thesealant 102.

Optionally, the proximal end 122 of the outer tubular member 120 mayinclude one or more features, e.g., an annular protrusion 123, thatlimits distal movement of the outer tubular member 120. For example, theannular protrusion 123 may abut a distal end of the housing 180 in thefirst position, thereby preventing further distal movement of the outertubular member 120, but allowing proximal motion from the first positiontowards the second position.

Optionally, the outer tubular member 120 and/or housing 180 may includea safety mechanism to prevent premature proximal movement of the outertubular member 120 from the first position. For example, an actuator(not shown) may be provided on the housing 180 that includes a detent,catch, or other feature (also not shown) that engages a pocket, matingdetent, catch, or other feature (also not shown) on the proximal end 122of the outer tubular member 120. With the features engaged, the outertubular member 120 may be restrained from proximal movement. During use,the actuator, e.g., a button, slider, latch, and the like, on thehousing 180 may then be actuated to release the features, therebyallowing the outer tubular member 120 to be directed proximally from thefirst position.

In addition or alternatively, similar actuators or releases may beprovided between the housing 180 and the occlusion member 140 forselectively preventing movement of the housing 180 relative to theocclusion member 140.

In another alternative, a removable spacer or other stop 190 may beprovided that may extend from the proximal end of the housing 180 to theproximal end 142 of the occlusion member 140. For example, the stop 190may be an elongate member having a “C” shaped cross-section, allowingthe stop 190 to be snapped or otherwise received around the occlusionmember 140. Alternatively, the stop 190 may be a tubular member receivedaround the occlusion member 140 that includes one or more weakenedregions, e.g., axial seams, that allow the stop 190 to separated andremoved from around the occlusion member 140.

The stop 190 may have sufficient length to abut the proximal end of thehousing 180 and the housing 148 on the proximal end 142 of the occlusionmember 140. The stop 190 may also have sufficient column strength toprevent the housing 180 from being directed proximally and causing thestop 190 to buckle or otherwise fail. Thus, with the stop 190 receivedaround the occlusion member 140, proximal movement of the housing 180may be substantially prevented. The stop 190 may be peeled or otherwiseseparated from around the occlusion member 40, e.g., by pulling tab orhandle 192, thereby allowing the housing 180 to be subsequently directedproximally. As shown in FIG. 4C, the housing 180, along with the innerand outer tubular members 170, 120 may then be directed proximally tothe third position to expose the sealant 102.

To facilitate retraction of the outer tubular member 120 from the firstposition to the second position, a raised slider ring or other radialelement 128 may be provided on the outer tubular member 120 between theproximal and distal ends 122, 124. The slider ring 128 may be attachedto an outer surface of the outer tubular member 120. Alternatively, theslider ring 128 may be integrally formed with the outer tubular member120 or may be a separate proximal extension attached to the outertubular member 120, e.g., at least partially defining the proximal end122 of the outer tubular member 120.

Optionally, the housing 180 may include one or more stops 184 forlimiting proximal movement of the outer tubular member 120 relative tothe housing 180. For example, as best seen in FIG. 4B, the stop(s) 184may be one or more tabs or walls extending at least partially across thehousing 180 such that the proximal end 122 of the outer tubular member20 abuts the stop(s) 184 when the outer tubular member 120 has beenretracted to the second position, thereby preventing further retractionof the outer tubular member 120, which may expose the inner tubularmember 170 and/or sealant 102 prematurely.

In addition or alternatively, the slider ring 128 may be located apredetermined distance from the proximal end 122 of the outer tubularmember 120 (and consequently the distal end of the housing 180) suchthat the slider ring 128 abuts the housing 180 when the outer tubularmember 120 is retracted to the second position, thereby preventingfurther proximal movement of the outer tubular member 120.

Optionally, the outer tubular member 120 and/or housing 180 may includeone or more detents, stops, pockets, or other features (not shown) thatsecure the outer tubular member 120 relative to the housing 180 when theouter tubular member 120 has been retracted to the second position. Forexample, the slider ring 128 may include an annular ridge (not shown)that may be received into a corresponding shaped recess (also not shown)in the distal end of the housing 180. The ridge and recess may be shapedto allow the ride to be forced into the recess, but not subsequentlyremoved. Alternatively, one or more detents or other interlockingconnectors may be provided on the proximal end 122 of the outer tubularmember 120 and the housing 180 or inner tubular member 170 that engageone another once the outer tubular member 120 has been directed to thesecond position. Thus, these feature(s) may prevent the outer tubularmember 120 from being advanced distally from the second position, e.g.,to cover again the exposed sealant 102, and/or may synchronizesubsequent movement of the outer tubular member 120 to movement of thehousing 180 and/or inner tubular member 170.

Similar to the previous embodiments, the pusher member 130 may include aproximal end 132, a distal end 134, and a lumen 136 extendingtherebetween. The pusher member 130 may be slidable over the occlusionmember 140, although the occlusion member 140 may include one or morestops 143 to limit proximal movement of the pusher member 130, whileallowing distal movement.

Similar to the method described above with respect to the FIGS. 3A-3D,the apparatus 110 may be used to deliver the sealant 102 within apuncture through tissue, e.g., communicating with a blood vessel orother body lumen (not shown). Initially, an introducer sheath may beplaced within the puncture 90, e.g., to provide access to vessel 94,similar to previous embodiments.

After completing any procedures performed via the introducer sheath, theapparatus 110 is introduced into the puncture through the introducersheath with the outer tubular member 120 in the first position shown inFIG. 4A. During this introduction, the transition cuff 150, if provided,may extend over the distal end 124 of the outer tubular member 120,e.g., to provide a smooth transition, seal the lumen 126 of the outertubular member 120, and/or otherwise facilitate introduction. Inparticular, the distal end 124 of the outer tubular member 120 may beintroduced into the introducer sheath, and advanced until the distal end124 is exposed within the vessel.

With the distal end 124 exposed within the vessel, the outer tubularmember 120 may be retracted to the second position shown in FIG. 4B. Asthe outer tubular member 120 is retracted, the transition cuff 150 isremoved from over the distal end 124, and may resiliently retract atleast partially from over the expandable member 146. As shown in FIG.4B, the expandable member 146 of the occlusion member 140 is fullyexposed when the outer tubular member 120 is retracted to the secondposition.

In an alternative embodiment, the apparatus 110 may be advanced untilthe slider ring 128 abuts the proximal end of the introducer sheath. Asthe apparatus 110 is advanced further, the slider ring 128 may preventfurther advancement of the outer tubular member 120, while the othercomponents of the apparatus 110 continue to be advanced. Thus, inessence, the outer tubular member 120 is retracted by advancing theother components of the apparatus 110, rather than pulling the outertubular member 120. This alternative may be advantageous, because it mayreduce a manipulating step by the user.

With the expandable member 146 of the occlusion member 140 exposedwithin the vessel, the expandable member 146 is expanded. As theexpandable member 146 is expanded, the transition cuff 150 may slide offthe expandable member 146, fold or otherwise, retract, and/or expandwith the expandable member 146.

The occlusion member 140 may then be at least partially withdrawn untilthe expanded expandable member 146 contacts the wall of the vessel,e.g., to substantially seal the vessel from the puncture. This mayinvolve a two-step, tactile process, as described elsewhere herein, inwhich the expanded expandable member 146 is withdrawn until it contactsthe distal end 164 of the introducer sheath and then until theexpandable member 146 contacts the wall of the vessel (thereby pullingthe introducer sheath partially out of the puncture). Tension in theproximal direction may be applied and/or maintained on the occlusionmember 140 to hold the expandable member 146 against the wall of thevessel and/or seal the puncture.

Turning to FIG. 4C, the housing 180 and inner and outer tubular members170, 120 may then be retracted to the third position to expose thesealant 102 within the puncture. This may be achieved by pulling theslider ring 128 on the outer tubular member 120, thereby pulling theouter tubular member 120 and housing 180 proximally out of the puncture.Alternatively, the introducer sheath may be pulled proximally, therebycausing the introducer sheath to abut the slider ring 128, and then thehousing 180 to withdraw the components of the apparatus 110 at leastpartially out of the puncture.

Similar to the previous embodiments, since occlusion member 140 includesstops 143 to prevent proximal movement of the pusher member 130 relativeto the occlusion member 140, the pusher member 130 may remainsubstantially stationary while the inner and outer tubular members 170,120 are retracted to expose the sealant 102 and the pusher member 130.Thus, the pusher member 130 may serve as a stop that prevents thesealant 102 from moving proximally while the inner tubular member 170around the sealant 102 is withdrawn.

In one embodiment, the user of the apparatus 110 may position his or herthumb on the pusher member 130 to maintain its position while the othercomponents of the cartridge 118 are retracted and/or removed entirelyfrom the puncture.

Optionally, the sealant 102 may then be tamped within the puncture,e.g., by advancing the pusher member 130 distally to press the sealant102 against the wall of the vessel and/or against the expandable member146, similar to the previous embodiments.

After delivering the sealant 102, the proximal tension on the occlusionmember 140 may be released, the expandable member 146 may be collapsed,and the occlusion member 140 may be slowly withdrawn through the lumenof the sealant 102. This may be achieved simply by pulling on theintroducer sheath until the housing 180 contacts the housing 148 of theocclusion member 140, and continuing to pull to pull the occlusionmember 140 out of the puncture.

After removing the occlusion member 140, the pusher member 130 may bewithdrawn, leaving the sealant 102 in place.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

1. An apparatus for sealing a puncture extending through tissue,comprising: an elongate occlusion member comprising a proximal end, adistal end sized for insertion into a puncture through tissue, and anexpandable member on the distal end; a cartridge carried on theocclusion member, the cartridge comprising: an outer tubular membercomprising a proximal end, a distal end sized for insertion into apuncture through tissue, and a lumen extending between the proximal anddistal ends; and a sealant disposed within the outer tubular memberadjacent the expandable member in a first position, the outer membermovable proximally from the first position to a second position toexpose the sealant; and a transition cuff on the occlusion member distalto the expandable member, the cuff extending over the outer memberdistal end in the first position and extending at least partially overthe expandable member when the outer member is moved from the firstposition to the second position.
 2. The apparatus of claim 1, whereinthe cartridge further comprises an inner pusher member disposed withinthe outer tubular member adjacent the sealant for preventing substantialproximal movement of the sealant when the outer member is moved from thefirst position to the second position to expose the sealant.
 3. Theapparatus of claim 1, further comprising a tubular sheath comprising aproximal end, a distal end sized for insertion into a puncture throughtissue, and a lumen extending between the proximal and distal ends forreceiving the cartridge therethrough.
 4. The apparatus of claim 1,wherein the transition cuff is sufficiently flexible to accommodateexpansion of the expandable member.
 5. The apparatus of claim 4, whereinthe cuff extends only partially over the expandable member such that thecuff is directed distally when the expandable member is expanded.
 6. Theapparatus of claim 4, wherein the cuff is sufficiently expandable suchthat the cuff expands when the expandable member is expanded.
 7. Theapparatus of claim 1, wherein the sealant comprises an elongate bodyhaving a disk shape, a solid cylindrical shape, a rolled sheetcylindrical shape, or a folded sheet cylindrical shape.
 8. The apparatusof claim 1, wherein the sealant comprises hydrogel.
 9. The apparatus ofclaim 8, wherein the sealant comprises a lyophilized hydrogel comprisinghydrolytically degradable bonds, the hydrogel expanding when exposed toan aqueous physiological environment.
 10. The apparatus of claim 1, thesealant comprising a lumen extending between proximal and distal endsthereof for receiving the occlusion member therethrough.
 11. A systemfor sealing a puncture extending through tissue, comprising: a deliverysheath comprising a proximal end, a distal end sized for insertion intoa puncture through tissue, and a lumen extending between the proximaland distal ends; an elongate occlusion member comprising a proximal end,a distal end sized for insertion into the introducer sheath lumen, andan expandable member on the distal end; a cartridge carried on theocclusion member, the cartridge comprising: an outer member comprising aproximal end, a distal end sized for insertion into the introducersheath lumen, and a lumen extending between the proximal and distalends; a sealant disposed within the outer member adjacent the expandablemember; and an inner pusher member disposed within the outer memberadjacent the sealant for preventing substantial proximal movement of thesealant, wherein the outer member is movable proximally from a firstposition where the outer member distal end covers the sealant and isdisposed adjacent the expandable member, to a second position forexposing the sealant.
 12. The system of claim 11, further comprising atransition cuff on the occlusion member distal to the expandable member,the cuff extending over the outer member distal end in the firstposition and extending at least partially over the expandable memberwhen the outer member is directed to the second position.
 13. The systemof claim 11, wherein the delivery sheath comprises an introducer sheathfor delivering one or more instruments through the puncture into apatient's body.
 14. The system of claim 11, wherein the transition cuffis sufficiently flexible to accommodate expansion of the expandablemember.
 15. The system of claim 14, wherein the cuff extends onlypartially over the expandable member such that the cuff is directeddistally when the expandable member is expanded.
 16. The system of claim14, wherein the cuff is sufficiently expandable such that the cuffexpands when the expandable member is expanded.
 17. The system of claim11, wherein the sealant comprises an elongate body having a disk shape,a solid cylindrical shape, a rolled sheet cylindrical shape, or a foldedsheet cylindrical shape.
 18. The system of claim 11, wherein the sealantcomprises a lyophilized hydrogel comprising hydrolytically degradablebonds, the hydrogel expanding when exposed to an aqueous physiologicalenvironment.
 19. The system of claim 11, the sealant comprising a lumenextending between proximal and distal ends thereof for receiving theocclusion member therethrough.
 20. The system of claim 11, furthercomprising a removable stop extending between the proximal end of theouter member and the proximal end of the occlusion member for preventingproximal movement of the outer member relative to the occlusion memberuntil the stop is removed.
 21. An apparatus for sealing a punctureextending through tissue, comprising: an elongate occlusion membercomprising a proximal end, a distal end sized for insertion into apuncture through tissue, and an expandable member on the distal end; anda cartridge carried on the occlusion member, the cartridge comprising:an outer tubular member comprising an outer member proximal end, anouter member distal end sized for insertion into a puncture throughtissue, and a lumen extending between the outer member proximal anddistal ends, the outer member movable from a first position wherein theouter member distal end at least partially covers the expandable memberand a second position wherein the expandable member is exposed; an innertubular member slidably disposed within the outer tubular member, theinner tubular member comprising inner member proximal and distal ends,the inner member distal end disposed adjacent the outer member distalend when the outer tubular member is in the second position; a sealantdisposed within the inner tubular member adjacent the inner memberdistal end; and a housing attached to the inner member proximal end, theouter tubular member being slidable axially relative to the housing, thehousing limiting axial movement of the outer tubular member between thefirst and second positions. 22-25. (canceled)
 26. A method for sealing apuncture extending through tissue to a body lumen, comprising: providingan apparatus comprising: an elongate occlusion member including anexpandable member on a distal end thereof; a tubular member slidablydisposed around the occlusion member; and a sealant disposed within thetubular member adjacent the expandable member; introducing the occlusionmember distal end into the puncture with the expandable member in acontracted condition until the expandable member and the sealant extendfrom the puncture into the body lumen; expanding the expandable member;at least partially withdrawing the occlusion member from the punctureuntil the expanded expandable member contact a wall of the body lumenadjacent the puncture, thereby withdrawing the sealant back into thepuncture; and withdrawing the tubular member to expose the sealantwithin the puncture. 27-31. (canceled)
 32. A method for sealing apuncture extending through tissue to a body lumen, comprising: providingan apparatus comprising: an occlusion member comprising an expandablemember on a distal end thereof; a cartridge comprising an outer memberand a sealant within the outer member adjacent the expandable member;and a transition cuff on the occlusion member distal to the expandablemember, the cuff extending over a distal end of the outer member;introducing the occlusion member distal end through the puncture intothe body lumen with the cuff extending over the distal end of the outermember; retracting the outer member to expose the expandable memberwithin the body lumen, the cuff extending at least partially over theexpandable member; expanding the expandable member within the bodylumen; and at least partially withdrawing the occlusion member from thepuncture until the expanded expandable member substantially seals thebody lumen from the puncture. 33-38. (canceled)